Current status: Closed
This consultation ran from August 22, 2024 to September 23, 2024.
About the consultation
The Canadian Food Inspection Agency (CFIA) was seeking comments on the following amended single ingredient feed (SIF) description for Kluyveromyces marxianus culture dehydrated.
Background
The Feeds Regulations, 2024 require a proponent to submit a pre-market application for new feed ingredients or SIFs that have been modified such that they differ from an approved SIF, or SIFs that are for a new purpose. The CFIA evaluates the information in the application to establish that the SIF is safe, effective, and labelled correctly.
Approved SIFs are listed and described in the Canadian Feed Ingredients Table (CFIT), which is incorporated by reference (IBR) into the Feeds Regulations, 2024. The CFIA's Incorporation by Reference Policy requires that a consultation be conducted before changes to IBR documents are made. Refer to Documents incorporated by reference under the Feeds Regulations, 2024 for additional information.
About the evaluation
The CFIA's Animal Feed Program (AFP) has completed a detailed evaluation of an application for the amendment of an existing SIF description: Kluyveromyces culture dehydrated.
The SIF name will be changed from Kluyveromyces culture dehydrated to Kluyveromyces marxianus culture dehydrated. The description will be amended to incorporate standardized wording as has been done for other viable microorganism descriptions listed under subclass 6.19.2 (Gut modifier ingredients – Viable microorganisms) of part 2 of the CFIT.
The evaluation considered information related to:
- the safety of feeding this SIF to livestock with respect to animal health
- the safety of foods derived from livestock that eat this SIF
- the safety of workers/bystanders exposed to this SIF
- environmental safety
- the fit-for-purpose and efficacy of this SIF for the intended livestock species
The results of the CFIA's evaluation of available scientific data supports the safety and efficacy of Kluyveromyces marxianus culture dehydrated for its intended purpose as a source of viable organisms for use as a component of gut modifier products for livestock species.
Amended SIF description
The CFIA intends to amend the existing SIF description for Kluyveromyces culture dehydrated under subclass 6.19.2 (Gut modifier ingredients – Viable microorganisms) of class 6 (Non-nutritive ingredients) in part 2 of the CFIT.
The SIF name will be changed to Kluyveromyces marxianus culture dehydrated and the description amended to incorporate standardized wording as has been done for other viable microorganism descriptions listed under subclass 6.19.2 (Gut modifier ingredients – Viable microorganisms) of part 2 of the CFIT.
The amended description is:
Kluyveromyces marxianus culture dehydrated
is the dried product composed of Kluyveromyces marxianus and its growth medium, which are dried in such a manner as to preserve the viability of the Kluyveromyces marxianus yeast. The culturing process of the microorganism shall be conducted in accordance with good manufacturing practices using a non-pathogenic strain of Kluyveromyces marxianus, which does not contain a novel trait. A microbial strain unique identifier shall be indicated on the label. It shall not contain other extraneous materials except in such amounts as may occur unavoidably during good manufacturing practices. The growth medium shall not be fortified with levels of minerals or vitamins above those required for optimal growth of the yeast cells.
It shall be labelled with the following statement:
"This ingredient is approved as a source of viable organisms for use as a component of gut modifier products for livestock species."
It shall be labelled with a guarantee for the minimum number of viable Kluyveromyces marxianus cells per gram.
Additional information
The modification to the name of this SIF (that is, to include the species-level identification of the microorganism in the SIF name) and the amended SIF description is the result of the CFIA's project to update viable microorganism descriptions.
This existing description was amended to include the species of the microorganism in the SIF name and to incorporate standardized wording as has been done for other viable microorganism descriptions listed under subclass 6.19.2 (Gut modifier ingredients – Viable microorganisms) of part 2 of the CFIT. In addition, changes were made to the required label guarantee and how the guarantee is to be expressed on the label. This change is the result of the methods provided to support the label guarantee during approval and registration of this part 2 SIF.
Note that there is only 1 registered source of this part 2 SIF, and therefore amendments will be made to the existing SIF description. The current description for Kluyveromyces culture dehydrated will be replaced and no longer found or maintained in the CFIT.
As the CFIA continues to work on updating how viable microorganisms are named and described in the CFIT, species-level identification of these microorganisms is important. The CFIA will request that registrants with registered sources of viable microorganisms and applicants who are submitting new applications for viable microorganisms include data to support a species-level identification and confirm the intended purpose when they submit an application for SIF approval or renewal. This will allow the CFIA to accurately name and describe the viable microorganisms approved for use in livestock feed in Canada.
Who was the focus of this consultation
Animal feed stakeholders, including:
- suppliers of feed ingredients
- commercial feed manufacturers
- feed importers, distributors and retailers
- industry associations
- other government departments
- international trading partners
- veterinarians
All comments are welcome from industry, governments, the public, or other organizations or individuals.
How to participate
The CFIA is seeking feedback on the amended description for Kluyveromyces marxianus culture dehydrated.
Stakeholders were encouraged to share comments if there was:
- concerns about the accuracy of the SIF description
- any scientific data that should be considered before the SIF is amended
The CFIA evaluators will review scientific questions or information for consideration in the evaluation. They will also evaluate non-scientific input and explore appropriate ways of addressing it.
Comments can be sent by email to the Animal Feed Program (AFP) at cfia.afp-paa.acia@inspection.gc.ca. Please use "Kluyveromyces marxianus culture dehydrated" in the subject line of the email. The CFIA was asking for comments and feedback by September 23, 2024, 30 days from the date of this posting.
Next steps
The CFIA will review all of the comments received. If no significant scientifically valid concerns are raised, the CFIA will finalize the approval of Kluyveromyces marxianus culture dehydrated and issue the approval to the applicant. If significant concerns are raised, the CFIA will evaluate the additional information and may, subject to the commenters' consent, forward the comments to the applicant for their response. A what we heard report that summarizes the feedback received will be published.
This amended SIF description will be added to the CFIT at the next update.
Related information
Contact us
Animal Feed Program (AFP)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Email: cfia.afp-paa.acia@inspection.gc.ca